Incidence of Retinal Vasculitis Among Patients Receiving Aflibercept: A US Real-World Evidence Study

Conditions

• Retinal Vasculitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• aflibercept 2mg — DRUG
  No study-specific interventions administered in this observational study

Study Details

This study will describe and estimate the incidence of Retinal Vasculitis (RV) events among patients and patient eyes receiving aflibercept intravitreal (IVT) (Eylea®, aflibercept 2mg) therapy in US clinical practice. The main objective is to describe demographic and clinical characteristics of patients receiving aflibercept 2mg injections, to estimate the incidence of RV and RV plus Intraocular Inflammation (IOI) following aflibercept 2mg injections and to describe characteristics of RV cases.

Key Dates

Start date

Jul 15, 2025

Status verified

Sep 2025

Primary completion

Aug 30, 2025

Completion

Sep 15, 2025

Study Design

Enrollment

290,000 participants (actual)

Arms

• Arm: Study Patients
  Patients ≥ 18 years of age, who received aflibercept 2mg IVT during the study period

Primary Outcome Measure

Incidence of RV events [ Time Frame: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 7 years ]

Locations (1)

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